The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Elecsys Troponin T Gen 5 Stat Assay, Elecsys Troponin T Gen 5 Stat Calset, Elecsys Precicontrol Troponin, Elecsys Troponin T Gen 5 Calcheck 5.
| Device ID | K162895 |
| 510k Number | K162895 |
| Device Name: | Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Contact | Jane Phillips |
| Correspondent | Jane E Phillips Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 |
| Product Code | MMI |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| Subsequent Product Code | JJY |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-17 |
| Decision Date | 2017-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613336148280 | K162895 | 000 |
| 07613336148273 | K162895 | 000 |